Mood & Mental Health

·

Study

Synthetic Psilocybin Passes Its First Phase 3 Depression Trial

Synthetic Psilocybin Passes Its First Phase 3 Depression Trial

Psilocybin mushrooms

What they found

A single 25 mg dose of COMP360 psilocybin improved MADRS depression scores by 3.6 points in a Phase 3 trial.

A single 25 mg dose of COMP360 psilocybin improved MADRS depression scores by 3.6 points in a Phase 3 trial.

The number

3.6-point improvement on the MADRS depression scale

How solid is it?

Early human

Early human

Human – RCT

Human – RCT

Evidence ladder: Lab dish → Animal → Early human → Strong human. Reviews summarize earlier research.

At a glance

Latin name

Compound

psilocybin (COMP360)

psilocybin (COMP360)

Published in

Business Wire

Business Wire

Covered in Shroom Scan

Section

PSILOCYBIN & LEGISLATION

PSILOCYBIN & LEGISLATION

As it ran in Shroom Scan

Clearing Phase 3

Clearing Phase 3

A synthetic psilocybin (COMP360) showed a 3.6-point improvement on the MADRS depression scale in a landmark Phase 3 trial for treatment-resistant depression, comparable to Spravato, the fast-acting nasal spray derived from ketamine and approved in 2019. The single 25mg dose showed no new safety issues or suicidality concerns. This is the first-ever Phase 3 success for a classic psychedelic, putting Compass Pathways one step closer to FDA approval and opening the door for legal psychedelic-assisted therapy.

A synthetic psilocybin (COMP360) showed a 3.6-point improvement on the MADRS depression scale in a landmark Phase 3 trial for treatment-resistant depression, comparable to Spravato, the fast-acting nasal spray derived from ketamine and approved in 2019. The single 25mg dose showed no new safety issues or suicidality concerns. This is the first-ever Phase 3 success for a classic psychedelic, putting Compass Pathways one step closer to FDA approval and opening the door for legal psychedelic-assisted therapy.

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